Evra

Norelgestromin 6 mg, ethinyl estradiol 600 mcg

Female contraception.

Use 1 patch at a time, apply each wk for 3 wk. On change day (day 8 & 15 of the cycle) remove used patch & apply a new one immediately. The 4th wk is patch-free starting on day 22 through day 28.

Hypersensitivity. Presence or risk of VTE; current (on anticoagulants) or history of [eg, DVT or pulmonary embolism (PE)]. Known hereditary or acquired predisposition for VTE eg, APC-resistance (including factor V Leiden), antithrombin-III, protein C & protein S deficiency. Major surgery w/ prolonged immobilization. High risk of VTE due to presence of multiple risk factors. Presence or risk of arterial thromboembolism (ATE); current or history of ATE (eg, MI) or prodromal condition (eg, angina pectoris). Cerebrovascular disease, current or history of stroke or prodromal condition (eg, transient ischaemic attack). Known hereditary or acquired predisposition for ATE eg, hyperhomocysteinaemia & antiphospholipid-Abs (anticardiolipin Abs, lupus anticoagulant). History of migraine w/ focal neurological symptoms. High risk of ATE due to multiple risk factors or presence of 1 serious risk factor eg, DM w/ vascular symptoms, severe HTN (persistent BP values of ≥160 mmHg systolic or ≥100 mmHg diastolic), severe dyslipoproteinaemia. Valvular heart disease w/ complications. Known or suspected carcinoma of the breast, endometrium or other known or suspected estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice w/ prior hormonal contraceptive use. Acute or chronic hepatocellular disease w/ abnormal liver function. Hepatic adenomas or carcinomas. Patients receiving drug combinations w/ paritaprevir/ritonavir, ombitasvir &/or dasabuvir due to potential ALT elevations. Known or suspected pregnancy.

Heavy smoking in women >35 yr. Body wt ≥90 kg. Take appropriate measures to rule out malignancy in case of undiagnosed, persistent or recurrent abnormal vag bleeding. Conditions which increase risk of developing VTE complications (eg, prolonged immobilization or major surgery, leg surgery or cast, obesity, family history of thromboembolic disease, inflammatory bowel diseases eg, Crohn's disease or ulcerative colitis); risk factors for arterial disease (eg, smoking, hyperlipidemia, HTN, obesity or conditions which increase the risk of arterial thromboembolic complications eg, SLE); severe migraine w/o aura; DM; severe depression or history of this condition; presence or history of cholelithiasis; chronic idiopathic jaundice; family history of cholestatic jaundice (eg, Rotor, Dubin-Johnson syndrome). Discontinue use immediately if thromboembolic disorders (thrombophlebitis, VTE including PE, cerebrovascular disorders & retinal thrombosis) occur. Discontinue use at least 4 wk prior to & for 2 wk after elective surgery associated w/ increased risk of thromboembolism during & following prolonged immobilization; unexplained partial or complete loss of vision, onset of proptosis or diplopia, papilledema or retinal vascular lesions; significant persistent BP elevation (160 mmHg systolic or ≥100 mmHg diastolic) occurs & cannot be adequately controlled. Regularly monitor BP throughout hormonal contraceptive therapy. Increased risk of developing hepatocellular carcinoma in combination hormonal contraceptive users. Possible gallbladder disease including cholecystitis & cholelithiasis. Possible risk of reproductive organ & breast carcinoma. May decrease glucose tolerance. Discontinue use if onset or exacerbation of migraines w/ or w/o focal aura; development of headaches w/ recurrent, persistent or severe new pattern occur. Possible bleeding irregularities. Possible chloasma; avoid sun or UV radition exposure. Renal impairment. Advise nursing mothers not to use Evra or other combination hormonal contraceptives if possible; use other forms of contraception until child is fully weaned. Not indicated for use before menarche. Not intended for use by post-menopausal women.

Application site reaction, breast symptoms (including breast discomfort & engorgement & female breast pain), nausea, headache & emotional lability.

Plasma conc & effectiveness may be decreased; increased breakthrough bleeding w/ enzyme (including CYP3A4) inducer drug or herbal products. May decrease effectiveness w/ some anti-epileptics (eg, carbamazepine, eslicarbazepine acetate, felbamate, oxcarbazepine, phenytoin, rufinamide, topiramate), (fos)aprepitant, barbiturates, bosentan, griseofulvin, some combinations of HIV PIs (eg, nelfinavr, ritonavir, ritonavir-boosted PIs), medications given in combination w/ HIV/AIDS drugs (eg, cobicistat), modafinil, some NNRTIs (eg, nevirapine), rifampin & rifabutin, St. John's wort. May increase plasma levels of ethinyl estradiol w/ acetaminophen, ascorbic acid, CYP3A4 inhibitors (including itraconazole, ketoconazole, voriconazole, fluconazole & grapefruit juice), etoricoxib, some HIV PIs (eg, atazanavir, indinavir), HMG-CoA reductase inhibitors (including atorvastatin & rosuvastatin), some NNRTIs (eg, etravirine). May increase plasma levels of cyclosporine, omeprazole, prednisolone, selegiline, theophylline, tizanidine, voriconazole. May decrease plasma levels of acetaminophen, clofibric acid, lamotrigine, morphine, salicylic acid, temazepam.

Other Contraceptives

G03AA13 - norelgestromin and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

POM